U.S. patent application number 16/461580 was filed with the patent office on 2020-02-27 for medical bag with two compartments and including a tab.
The applicant listed for this patent is Technoflex. Invention is credited to Emmanuel Arnault, Fabien Pruvot.
Application Number | 20200060934 16/461580 |
Document ID | / |
Family ID | 58347509 |
Filed Date | 2020-02-27 |
![](/patent/app/20200060934/US20200060934A1-20200227-D00000.png)
![](/patent/app/20200060934/US20200060934A1-20200227-D00001.png)
![](/patent/app/20200060934/US20200060934A1-20200227-D00002.png)
United States Patent
Application |
20200060934 |
Kind Code |
A1 |
Pruvot; Fabien ; et
al. |
February 27, 2020 |
MEDICAL BAG WITH TWO COMPARTMENTS AND INCLUDING A TAB
Abstract
A medical bag having at least two compartments, a peelable seal
between the compartments, a permanent seal on the contour of the
bag and at least one filling tube further comprising an opening
with no seal on one of the compartments. The at least one tube for
filling, comprises an opening with no seal on one of the
compartments, and it comprises two labels on the compartment, a
label being located on the rear side and the other label being
located on the front face of the bag, the opening onto one of the
compartments constituting a film excess on top of a label, the
excess being sealed only on one of the sides, but not horizontally
and being flexible enough to facilitate easy opening.
Inventors: |
Pruvot; Fabien; (Saint Pee
Sur Nivelle, FR) ; Arnault; Emmanuel; (Tarnos,
FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Technoflex |
Bidart |
|
FR |
|
|
Family ID: |
58347509 |
Appl. No.: |
16/461580 |
Filed: |
November 13, 2017 |
PCT Filed: |
November 13, 2017 |
PCT NO: |
PCT/FR2017/053088 |
371 Date: |
May 16, 2019 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61J 1/2024 20150501;
A61J 1/2093 20130101; A61J 1/1475 20130101; A61J 1/10 20130101;
B65D 81/3266 20130101 |
International
Class: |
A61J 1/20 20060101
A61J001/20; A61J 1/10 20060101 A61J001/10; A61J 1/14 20060101
A61J001/14 |
Claims
1. A bag (10) for medical purposes having at least two compartments
(11, 12), a peelable seal (13) between the compartments (11, 12), a
permanent seal (14) on the contour of said bag (10) and at least
one tube (15) for filling, characterised in that it comprises an
opening (16) with no seal on one of the compartments (11, 12), and
in that it comprises two labels on the compartment (11), a label
being located on the rear side and the other label being located on
the front face of said bag (10), the opening (16) onto one of the
compartments (11, 12) constituting a film excess on top of a label,
said excess being sealed only on one of the sides, but not
horizontally and being flexible enough to facilitate easy
opening.
2. A bag (10) for medical purposes having at least two compartments
(11, 12) according to claim 1, characterised in that it is
manufactured from two transparent films prior to the placement of
said labels.
3. A bag (10) for medical purposes having at least two compartments
(11, 12) according to one of the preceding claims, characterised in
that it comprises means so that, upon breaking of said peelable
seal (13), the entire width of said peelable seal (13) does not
yield under pressure.
4. A bag (10) for medical purposes having at least two compartments
(11, 12) according to claim 1, characterised in that at least one
of the two labels is peelable, that is to say, it is adapted to be
removed before use of said bag (10).
5. A bag (10) for medical purposes having at least two compartments
(11, 12) according to one of the preceding claims, characterised in
that said opening (16) does not present any horizontal seal on one
of the compartments (11, 12).
6. A bag (10) for medical purposes having at least two compartments
(11, 12) according to one of claims 1 to 5, characterised in that
said opening (16) has no vertical sealing on one of the
compartments (11, 12).
7. A bag (10) for medical purposes having at least two compartments
(11, 12) according to one of the preceding claims, characterised in
that it comprises two compartments (11, 12).
8. An assembly characterised in that it comprises a bag (10) for
medical purposes according to one of the preceding claims and in
that it comprises a complex/overpack for packaging said filled bag.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to the field of medical bags.
The present invention relates more particularly to a medical bag
with two compartments and including a tab.
PRIOR ART
[0002] Bags for medical use with two compartments are known in the
prior art. For example, one of the two compartments is filled with
a liquid (diluent) and the other compartment contains a powder
(drug).
[0003] The prior art known from U.S. Pat. No. 6,468,377 B1, is a
flexible container for storage and administration of medical
solutions. The container comprises a transparent front sheet
consisting of a flat layer of a polymer and an opposite back sheet.
The back sheet is made of a flat laminate layer. The front and rear
sheets are sealed together along a common peripheral edge to form a
volume enclosure. The volume enclosure is made of materials having
barrier properties to oxygen and moisture which make it possible
for the thermoplastic material of the container to be stored for
extended periods of time without degrading the contents. The volume
enclosure is then inflated with a pressurised gas to stretch
permanently the front and rear sheets outwardly and thereby to
increase the volume capacity of the recipient. An alternative
embodiment of the recipient comprises multiple compartments
separated by moveable seals, for containing a diluent and a
medicament. The seals are ruptured by manipulation of the recipient
to mix the contents and at the same time for administration to a
patient by means of an IV type arrangement. Lateral side tubes are
provided for filling the bag, as shown in FIG. 6 of this prior art
US patent. On said FIG. 6, a connector/tube for filling the
container with liquid and a connector/tube for filling the
container with powder can be seen. The filling compartment is then
removed/cut and then sealed to obtain the finished product, as
shown in FIGS. 1 and 2 of this prior art US patent.
DISCLOSURE OF THE INVENTION
[0004] The present invention intends to overcome the disadvantages
of the prior art by providing a medical bag with two compartments
for easier filling.
[0005] To this end, the present invention relates, in its most
general sense, to a medical bag having at least two compartments, a
peelable seal between the compartments, a permanent seal on the
contour of said bag and at least one filling tube further
comprising an opening with no seal on one of the compartments.
[0006] This opening having no seal on one of the compartments,
hereafter called "tab" makes filling easier. Indeed, during
filling, a specific opening system, for example suction cups, is
positioned on the bag to spread the front part of the rear section
and to make it possible to insert a filling nozzle. This opening
system requires having the most flexible possible films, hence the
importance of not placing aluminium in this area.
[0007] Moreover, if the excess was not present, there would be a
risk of filling the container with powder between the aluminium and
the bag, which is not desirable.
[0008] This excess actually makes it possible to properly open and
insert the powder between the two transparent films.
[0009] Preferably, the compartment having said opening is intended
to receive a powder.
[0010] Advantageously, said bag comprises two labels located on the
compartment for receiving a powder, one label being located on the
rear side and the other label being located on the front side of
said bag.
[0011] According to one embodiment, said bag is made from two
transparent films before said labels are placed thereon.
[0012] The fact of using a transparent film in direct contact with
the powder and the liquid makes it possible to better comply with
regulatory standards, insofar as it is more inert material and less
contaminating. The complex containing aluminium, present in the
labels, is not in direct contact with the solution, unlike the bags
of the prior art.
[0013] According to an embodiment, said bag implements a
complex/overpack for packaging said filled bag. This increases the
service life and protects the bag from outside contamination.
[0014] Advantageously, the other compartment is intended to receive
a liquid and said bag is transparent in the portion of the bag
which receives said liquid, and is also transparent in the portion
of the bag receiving said powder when said labels are removed. This
makes a visual check possible.
[0015] According to an embodiment, said bag is adapted to be folded
and to be kept folded thanks to the overpack. This allows the
peelable seal to be protected.
[0016] Advantageously, said liquid is located in the bottom of the
bag. If used without breaking the peelable seal, then only the
liquid, which is a solvent, for example a sugared salt water, will
be administered to the patient without risk.
[0017] According to a particular mode of implementation, said bag
comprises means that make it possible, upon rupture of said
peelable seal, for the entire width of said peelable seal to not
yield under pressure. This causes a liquid inlet jet often located
in the middle of the peelable seal. Said jet generates a vortex
that facilitates the homogenisation of the powder into the
solution.
[0018] Alternatively, at least one of the labels is sealed to said
bag, and, when the label is being sealed onto said bag, the label
is held by a suction device, the bag being then put into position
after which the seal is made. This holding via suction makes a
robust and repeatable process possible when sealing the label onto
the bag.
[0019] Alternatively, at least one of the labels is sealed to said
bag after filling of said bag. This makes it possible for the
entity that fills the bag to monitor the filling process ("visual
inspection" in English terminology) before applying the labels.
[0020] Advantageously, at least one of the two labels is peelable,
that is to say, it is capable of being removed before use of said
bag. These labels have the same level of adhesion, regardless pf
the temperature used during the sealing process, as a peelable film
is used as an inner layer of said label.
[0021] According to an embodiment, said opening does not present
any horizontal seal on one of the compartments.
[0022] According to another embodiment, said opening does not have
any vertical seal on one of the compartments.
[0023] According to an embodiment, said bag comprises two
compartments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The invention will be better understood using the
description given hereinafter for purely explanatory purposes, of
an embodiment of the invention, with reference to the Figures in
which:
[0025] FIG. 1 shows the bag of present invention in one
embodiment;
[0026] FIG. 2 shows the bag according to the present invention,
with two labels sealed to the upper part in one embodiment; and
[0027] FIG. 3 shows a bag compartment according to the present
invention after filling, in one embodiment.
DETAILED DESCRIPTION OF EMBODIMENTS OF INVENTION
[0028] The present invention relates to a bag 10 for medical
purposes having at least two compartments 11, 12, a peelable seal
13 between the compartments 11, 12, a permanent seal 14 around the
edge of said bag 10 and at least one filling tube 15, further
comprising an opening 16 having no seal on one of the two
compartments 11, 12.
[0029] In one embodiment, said opening 16 does not have any
horizontal seal on one of the compartments 11, 12.
[0030] In another embodiment, said opening 16 does not have any
vertical seal on one of the compartments 11,12.
[0031] In one embodiment, said bag comprises two compartments 11,
12.
[0032] FIG. 1 illustrates the bag 10 according to the present
invention, in one embodiment. It is observed in FIG. 1 that the bag
10 of the present invention comprises two compartments and 12, a
peelable seal 13 which can be broken under pressure, a permanent
seal 14 around the edge of said bag 10 and a filling tube 15. Also
shown in FIG. 1, the bag 10 of the present invention includes an
opening 16 having no horizontal seal on the compartment 11.
[0033] The bag 10 according to the present invention exhibits
permanent seals, the peelable seals (poor sealing intended to be
broken upon final use) and also an opening called a tab which does
not present any horizontal seal.
[0034] In one embodiment, the bag 10 according to the present
invention has a filling tube and a "tab" on the top of the bag
making it possible to open the bag along its entire width; this
will also make it possible to fill the container with one of the
components.
[0035] The compartment 12 of the bag 10 according to the present
invention comprising a tube 15 is filled through the tube 15
according to a standard method, the compartment 11 comprising the
tab is filled by separating the two films and then incorporating a
filling nozzle in the bag.
[0036] Once this filling is done, the filling nozzle is removed so
that a sealing tool makes a seal, at least, on the upper part of
the bag and, at most, along the entire width thereof.
[0037] In one embodiment, the bag 10 according to the present
invention comprises an open area that does not represent the entire
width of the bag 10.
[0038] In one embodiment, the bag 10 of the present invention also
has labels, one on the back and one on the front of the bag. These
labels are located on the compartment which will receive the powder
(compound sensitive to water vapor, light and oxygen and therefore
requiring the presence of an aluminium barrier).
[0039] These labels are used to provide additional protection to
the powder, with respect to the protection of the transparent
plastic film alone INERTA 108, and may be sealed to the bag either
before or after filling the bag 10.
[0040] FIG. 2 shows the bag according to the present invention,
with two labels sealed on the upper part, in one embodiment.
[0041] FIG. 2 shows the label aluminium, a sealed zone of the label
and seals on three sides for a holding the label on the front
bag.
[0042] If it is positioned prior to filling, the label is sealed on
at most three sides simply because the bag 10 according to the
present invention does not have areas capable of receiving a
sealing prior to filling the container with powder on the upper
part. While the fourth seal of the label was performed by heat
transfer, a seal inside the compartment (between the two
transparent films) would also be present and would block the
filling. However, if the label(s) are placed after filling, one can
imagine that during the placement of these labels, the four seals
will be done simultaneously.
[0043] The label is sealed to a portion of the powder compartment
to allow the tabs to go therebeyond, which is necessary if the tags
are sealed before filling, and optional if they are sealed after
filling.
[0044] FIG. 3 illustrates a bag compartment according to the
present invention after filling, in one embodiment.
[0045] FIG. 3 shows the excess of the film going beyond the
tab.
[0046] The excess of film going beyond the tab makes it possible to
provide a proper opening and makes it possible to fill the
container with powder between the two transparent films. In
section, the structure looks like this:
Alu (INERTA 161)/transparent film (INERTA108)/Powder/transparent
film (INERTA108)/Alu (INERTA 161)
[0047] It is necessary to avoid putting the powder between the
aluminium and the transparent film, which this tab makes
possible.
[0048] The filler device should be a machine capable of adroitly
making said opening. For example, a suction system applied to the
tab can be adapted to make it possible to open the compartment.
[0049] This excess of film going therebeyond is not only used for
the filling. It also increases the size of the powder compartment
to reduce powder drifting onto the seal area. This dust is indeed a
contaminant and a troublesome element for achieving a reliable
seal.
[0050] Said tab also makes it possible to seal the top bag and to
make the hanging hole. After sealing the top of the bag with a wide
seal, a portion thereof may be perforated to make the hanging hole
(hole for hanging the bag in hospitals).
[0051] The sealing of the bag makes it possible to finish attaching
the labels and to seal the powder compartment under the label. It
is wide enough to cover both the transparent area and the label
area. Indeed, the powder should not be able to back up into the tab
(transparent portion), which would not then be protected by the
aluminium.
[0052] It is in this tab that the suspension hole is then made.
[0053] The opening 16 does not have any horizontal or vertical seal
on any of the compartments 11, 12, also referred to as "tab" is an
excess where the film/bag goes beyond the top of the label (at
least on an empty bag). If it is desirable to have bags without
labels and place said labels after filling, this excess will be
present but not identifiable as an excess going beyond the label
but as a longer bag length.
[0054] This excess may be visible before or after filling, because
the labels themselves may be made before and after filling.
[0055] This excess is only sealed on both sides but not
horizontally, and is flexible enough to allow easy opening.
[0056] This tab will be made with a material compatible with
pharmaceutical products to ensure compatibility with the component
placed in the bag, and is sealed after filling.
[0057] In one embodiment, a suspension hole is formed in this
tab.
[0058] Empty bags made with the tab are produced and packaged in a
clean room to avoid particulate contamination inside the bag that
could occur since a portion thereof is open.
[0059] Furthermore, in one embodiment, the tab is covered with
aluminium labels where removal of the labels takes place after
filling.
[0060] The dimensions, and in particular the height, of this tab
will be defined so as to avoid the presence of residues in this
area after filling.
[0061] The transparent film used for this strip is a film
compatible with pharmaceutical products, for example INERTA 108,
and may be sealed to make it possible to store solution. In one
embodiment, the film is "peelable" in order to realise the peelable
seals.
[0062] In one embodiment, the bag 10 according to the present
invention comprises a filler tube at said tab to facilitate filling
of the container with powder.
[0063] In one embodiment, the compartment 11 with said opening 16
for receiving a powder.
[0064] In one embodiment, the bag 10 according to the present
invention comprises two labels located on the compartment 11 for
receiving a powder, a label being located on the rear side and the
other label being located on the front face of said bag 10.
[0065] In one embodiment, the bag 10 according to the present
invention is made from two transparent films before depositing said
labels.
[0066] In one embodiment, the bag 10 according to the present
invention uses a complex/overpack for packaging said filled
bag.
[0067] In one embodiment, the other compartment 12 is intended to
receive a liquid and said bag is transparent in the portion of the
bag 10 which receives said liquid, and is also transparent in the
portion of the bag 10 which receives said powder when said labels
are removed.
[0068] In one embodiment, the bag 10 according to the present
invention is adapted to be folded and to be kept folded thanks to
the overpack.
[0069] In one embodiment, said liquid is located on the bottom of
the bag.
[0070] In one embodiment, the bag 10 according to the present
invention comprises means for, upon breaking of said peelable seal
13, the entire width of said peelable seal 13 does not yield under
pressure.
[0071] In one embodiment, at least one label is sealed on said bag
10 and, during the sealing process of the label on said bag 10, the
label is held by a suction device, the bag is then positioned and
the seal is made.
[0072] In one embodiment, at least one of the labels is sealed to
said bag 10 after filling of said bag 10.
[0073] In one embodiment, at least one of the two labels is
peelable, that is to say, it is adapted to be removed before use of
said bag 10.
[0074] The label(s) reinforce(s) the peelable seal which separates
the components (the force/pressure required to open this peel is
greater with the label(s) or without). This reinforces the
protection of the peelable seal that should not yield before
removing the labels and use thereof.
[0075] The invention is described in the foregoing by way of
example. It is understood that a person skilled in the art is able
to produce different variants of the invention without departing
from the scope of the patent.
* * * * *